BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG

    MDR report key: 3033496 · Received April 3, 2013

    Report

    Report Number
    1719045-2013-00874
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WEIGHT WAS REPORTED AS (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD REPORTS THE PRODUCT CONFORMED TO ALL REQUIREMENTS. IT SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. UNIVERSAL PUNCH MANUFACTURED THE T25 STARDRIVE SCREWDRIVER, T-HANDLE, MATRIX, PART (B)(4), LOT 6457244. THE LOT INITIALLY CONFORMED TO SPECIFICATIONS AND WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THE SHAFT DIAMETER WAS MEASURED NEAR THE BROKEN TIP AND IT PASSED SPECIFICATIONS. THE TIP COULD NOT BE MEASURED DUE TO DAMAGE. THE RAW MATERIAL WAS CHECKED WITH A NITON GUN AND PASSED SPECIFICATIONS. DUE TO AN UNKNOWN CAUSE, THE T25 STARDRIVE TIP BROKE OFF. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES PART #03.632.036: THE HOLDING SLEEVE IS DESIGNED FOR A RETAINMENT OF THE MATRIX PEDICLE SCREWS DURING INSERTION AND REMOVAL. THE HOLDING SLEEVE HAS MINIMAL DAMAGE TO THE THREADS AND STILL FUNCTIONS AS INTENDED. THE THREADS MAY HAVE BEEN NICKED DUE TO THE BROKEN SCREW THREAD. THE MATERIALS WERE REVIEWED AND ARE ADEQUATE FOR THE INTENDED USE. PART #03.632.074: THE T-HANDLE DRIVER (LOT # 6457243) HAS TWISTED THREADS CONSISTENT WITH ATTEMPTED REMOVAL. THE TORQUE APPLIED CAUSED STRESSES WHICH WERE ABOVE THE MATERIAL YIELD STRENGTH. THE OTHER DRIVER (LOT# 6457244) IS YIELDED AND FRACTURED. THE STRESSES CREATED ON THE DRIVER TIP WERE ABOVE THE MATERIAL YIELD AND ULTIMATE TENSILE STRENGTH CAUSING THE FRACTURE IN ADDITION TO THE TWISTING. THE TECHNIQUE GUIDE WARNS AGAINST USING FIXED HANDLE DRIVERS DURING REMOVAL OF THE LOCKING CAPS: NEVER USE A FIXED OR RATCHETING T-HANDLE SCREWDRIVER FOR THIS TECHNIQUE. IF THE TORQUE LIMITING ATTACHMENT IS NOT USED, BREAKAGE OF THE DRIVER MAY OCCUR AND COULD POTENTIALLY HARM THE PATIENT. THE MATERIALS WERE REVIEWED AND ARE ADEQUATE FOR THE INTENDED USE. THE HOLDING SLEEVE FUNCTIONS AS INTENDED. THE DRIVERS WERE USED INCORRECTLY AS THEY ARE NOT MEANT TO BE USED FOR REMOVAL OF LOCKING CAPS.

    Description of Event or Problem · 1

    DURING L5-S1 LUMBAR FUSION PROCEDURE ON (B)(6) 2013, THE SURGEON WAS HALF WAY THROUGH PLACING A 7.0 MM TITANIUM MATRIX SCREW AT THE S1 LEVEL, A SMALL RING OF METAL AT THE TOP OF THE SCREW SNAPPED OFF, WHERE THE HOLDING SLEEVE CONTACTS THE SCREW. WHILE BACKING OUT THE SCREW, THE REPLACED SCREWDRIVER THREADS WERE DAMAGED. THE LOCKING HOLDING SLEEVE ALSO HAD THREADS DAMAGED AND WAS UNABLE TO BE USED. THE SURGEON USED ANOTHER SCREWDRIVER AND SUCCESSFULLY PLACED THE SCREW AT LEVEL S1. ONCE THE CONSTRUCT WAS FINISHED AND THE HEADS WERE PLACED INTO LOCKING CAPS AFTER FINAL TIGHTENING, THE SURGEON DECIDED TO REDIRECT ONE OF THE LOCKING CAPS. THE SURGEON WAS UNABLE TO REMOVE THE LOCKING CAP. WHILE TRYING TO REMOVE THE LOCKING CAP A STANDARD DRIVER AND A STARDRIVE SCREWDRIVER SHEARED OFF AND ANOTHER STARDRIVE SCREWDRIVER BECAME DEFORMED. THE SURGEON USED A METAL CUTTING BURR TO CUT THE ROD THAT STILL IS STUCK INSIDE THE HEAD OF THE SCREW AND USED A COUNTER TORQUE DEVICE TO REMOVE THE SCREW. ALL PARTS WERE RETRIEVED, THE PROCEDURE WAS DELAYED APPROXIMATELY ONE HOUR DUE TO THE EVENTS LISTED. THIS IS FOR A T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG. THIS IS REPORT 6 OF 8 PARTS FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    THIS IS 6 OF 8 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136578 T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG HXX SYNTHES MONUMENT 6457244

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention